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EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY

8 сентября 2026 г. обновлено: Aynur Ülkü, Karabuk University

THE EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY

A randomized controlled experimental study has been conducted to determine the effects of Enhanced Recovery After Surgery (ERAS) protocols on patient outcomes in the Cardiovascular Surgery Clinic.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

This randomized controlled trial was conducted to evaluate the effects of an Enhanced Recovery After Surgery (ERAS) protocol on postoperative recovery and patient outcomes in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The study was conducted in the Cardiovascular Surgery Clinic of Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. A total of 50 patients who met the eligibility criteria were included in the study and randomly assigned to either the ERAS group (n=25) or the control group (n=25). Patients in the ERAS group received a comprehensive perioperative care program based on ERAS principles. The ERAS program included preoperative oral carbohydrate loading, multimodal analgesia, prevention of postoperative nausea and vomiting, early extubation, respiratory exercises, coughing exercises, early mobilization, and other evidence-based perioperative interventions. Patients in the control group received routine perioperative care according to standard clinical practice. The primary outcomes included quality of recovery and postoperative clinical outcomes. Quality of recovery was assessed using the Quality of Recovery-40 (QoR-40) questionnaire. Secondary outcomes included anxiety, pain intensity, nutritional risk, postoperative delirium, and cardiovascular surgery-related symptoms. Clinical recovery outcomes included time to extubation, duration of intensive care unit stay, duration of surgical drain use, time to urinary catheter removal, time to first bowel movement, time to first oral intake, and length of hospital stay. Patients were evaluated at multiple time points throughout the postoperative recovery process. Assessments were performed during the intensive care unit stay, after transfer to the surgical ward, at hospital discharge, and at one week and one month after discharge. These repeated assessments were used to evaluate changes in quality of recovery, anxiety, pain, cardiovascular surgery-related symptoms, and other patient outcomes over time. The study aimed to determine whether implementation of a comprehensive ERAS protocol could improve quality of recovery, reduce postoperative symptoms and anxiety, facilitate earlier recovery, shorten intensive care unit and hospital stays, and contribute to improved clinical outcomes in patients undergoing cardiovascular surgery.

Тип исследования

Интервенционный

Регистрация (Действительный)

50

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Турция (Туркие)
      • Bolu, Турция (Туркие)
        • Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • Being admitted for their first planned coronary artery bypass graft (CABG) surgery;
  • Undergoing off-pump coronary artery bypass (OPCAB) surgery without the use of a cardiopulmonary bypass machine;
  • Not undergoing any additional surgical procedure during CABG surgery;
  • Having no abnormalities in preoperative laboratory parameters, including hemoglobin, albumin, and electrolytes;
  • Having no cognitive impairment;
  • Having no psychological or mental disorder;
  • Being able to speak Turkish and communicate effectively;
  • Being at least literate;
  • Being 18 years of age or older;
  • Being reachable by telephone during the follow-up period; and
  • Providing informed consent to participate in the study.

Exclusion Criteria:

  • Having previously undergone CABG surgery;
  • Undergoing CABG surgery using cardiopulmonary bypass with the heart arrested;
  • Undergoing any additional surgical procedure during CABG surgery;
  • Having electrolyte abnormalities in preoperative laboratory parameters;
  • Having cognitive impairment;
  • Having a psychological or mental disorder;
  • Being unable to speak Turkish, communicate effectively, or provide consent to participate in the study;
  • Being unable to read and write;
  • Being younger than 18 years of age;
  • Being unreachable by telephone during the follow-up period;
  • Withdrawing from the study after initially agreeing to participate;
  • Undergoing any surgical operation after hospital admission; or
  • Dying during the study intervention or follow-up period.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: ENHANCED RECOVERY AFTER SURGERY (ERAS) GROUP
Patients in the ERAS group received a multimodal enhanced recovery program covering the preoperative, intraoperative, and postoperative periods. Interventions included patient education and counseling, nutritional assessment and support when indicated, preoperative oral carbohydrate loading, appropriate fasting, and avoidance of mechanical bowel preparation. Intraoperative interventions included multimodal anesthesia, lung-protective ventilation, maintenance of normothermia, antimicrobial prophylaxis, blood conservation, and minimization of surgical drains. Postoperative care included early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, multimodal analgesia, thromboprophylaxis, glycemic control, wound care, delirium screening, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed during
Поведенческий: Enhanced Recovery After Surgery (ERAS) Protocol
A comprehensive 31-factor Enhanced Recovery After Surgery (ERAS) program was implemented throughout the perioperative period in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The program included patient education and counseling, nutritional assessment, preoperative oral carbohydrate loading, appropriate fasting, avoidance of mechanical bowel preparation, multimodal anesthesia and analgesia, lung-protective ventilation, normothermia, antimicrobial prophylaxis, blood conservation, prevention of postoperative nausea and vomiting, early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, thromboprophylaxis, glycemic control, systematic delirium screening, wound care, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed at predefined postoperative time points.
Без вмешательства: CONTROL GROUP
Patients in the control group received routine perioperative care according to standard clinical practice. No specific Enhanced Recovery After Surgery (ERAS) protocol was applied. Patients received standard preoperative, intraoperative, and postoperative care, including routine monitoring, pain management, respiratory care, mobilization, nutritional management, and other clinical interventions as indicated by the treating healthcare team. Patient outcomes were assessed at the same time points as in the ERAS group.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Quality of Recovery-40 (QoR-40) Score
Временное ограничение: one month
The scale is a 5-point Likert-type scale, and the total score ranges from 40 to 200 based on the sum of all items. A higher total score indicates that the patients' emotional and physical well-being is at the expected and favorable level following surgery, whereas a lower score indicates that their well-being has been adversely affected. With a Cronbach's alpha value of 0.936, the questionnaire is a valid and reliable instrument for assessing recovery following
one month

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Cardiac Surgery-Related Symptom Score
Временное ограничение: one month
The inventory is unidimensional and consists of 35 items. It is a Likert-type instrument, with each item scored from 0 to 4. The total score ranges from 0 to 140, with higher scores indicating greater symptom severity. The inventory has a total Cronbach's alpha coefficient of 0.961, and the total item correlations for all items are positive.
one month

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
State-Trait Anxiety Inventory Score
Временное ограничение: 1 month
The State-Trait Anxiety Inventory (STAI) was developed to assess individuals' state and trait anxiety levels separately. The scale consists of two sections and 40 items. The first section, the State Anxiety Inventory, assesses how the individual feels at a particular moment, whereas the second section, the Trait Anxiety Inventory, assesses the individual's general feelings and anxiety tendency. Higher total anxiety scores indicate higher levels of anxiety. The scale has a Cronbach's alpha coefficient of 0.76.
1 month
Postoperative Delirium
Временное ограничение: One month
The scale assesses eight domains: attention deficit, altered level of consciousness, hallucinations, psychosis, delusions, disorientation, psychomotor retardation or agitation, inappropriate affect or speech, sleep-wake cycle disturbance, and fluctuating course of symptoms. Negative findings are scored as 0, while positive findings are scored as 1. Patients with a total score of 4 or higher are considered to have delirium
One month

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Karabuk University

Следователи

  • Главный следователь: Aynur Ülkü, Karabuk Universty

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

30 октября 2024 г.

Первичное завершение (Действительный)

30 октября 2024 г.

Завершение исследования (Действительный)

30 мая 2025 г.

Даты регистрации исследования

Первый отправленный

8 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

8 сентября 2026 г.

Первый опубликованный (Действительный)

14 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

14 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

8 сентября 2026 г.

Последняя проверка

1 октября 2024 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • KarabukU-AUlku-1

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

Individual participant-level data will not be shared publicly due to patient privacy and confidentiality requirements. However, the aggregated results of the study will be reported and made available through scientific publication. No personally identifiable patient information will be included in the published results.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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